Kolon Life Science Registers Canadian Patent for Efficacy Evaluation Method of Osteoarthritis Cell and Gene Therapy

Patent for TG-C Efficacy Evaluation Method
Establishing Objective Criteria for the Therapeutic Effect of Cell Therapy Products

Kolon Life Science announced on August 11 that a patent for the "method for evaluating the efficacy of cell therapy products" related to TG-C (formerly Invossa), a cell and gene therapy for osteoarthritis under development by its affiliate Kolon TissueGene, has been approved for registration in Canada.

Kolon Life Science headquarters. Photo by Kolon Life Science

This patent was jointly filed by Kolon Life Science and Kolon TissueGene. Following approvals in the United States, Japan, China, Australia, Hong Kong, and Singapore, the decision to register in Canada further strengthens the technical reliability and market exclusivity foundation necessary for the global commercialization of TG-C.

TG-C is a cell and gene therapy composed of two components: the first component consists of allogeneic chondrocytes derived from cartilage, and the second component is a genetically modified cell line introduced with irradiated TGF-β1 (a gene that suppresses inflammation and promotes cartilage component production). These two components are mixed in a 3:1 ratio and injected into the knee joint cavity. This approach helps suppress joint inflammation, thereby alleviating pain and improving joint function and structure.

The core of the patent lies in establishing criteria for quantitatively evaluating the efficacy and quality of TG-C. The patent designates the expression levels of TGF-β1, secreted by the genetically modified cells in the second component, and TSP-1, produced by the chondrocytes in the first component, as key efficacy evaluation indicators. TSP-1 is a multifunctional protein involved in maintaining immune homeostasis. When these components are expressed above a certain threshold, it can be confirmed that the therapeutic effect of the produced therapy remains consistent.

This technological foundation is expected to serve as a critical driving force for TG-C's future global expansion. Cell therapies are based on living cells and are highly sensitive to even minor changes in raw materials, culture conditions, and process parameters. Ensuring consistent quality is considered a core challenge throughout the entire process from development to commercialization. Therefore, regulatory authorities and partners place great importance on whether there are clear evaluation criteria to scientifically verify the efficacy and reproducibility of the therapy's quality.

The regional significance of this patent is also considerable. Canada, along with major markets such as the United States and Europe, is recognized as a technologically advanced country with stringent regulatory standards. In particular, it is regarded as an emerging market experiencing rapid growth in the cell therapy sector. According to global market research firm Spherical Insights, the Canadian cell therapy market is expected to grow at an average annual rate of 24.29% from 2023 to 2033, reaching approximately $1.0605 billion (about 1.4738 trillion KRW) by 2033.

Kim Sunjin, CEO of Kolon Life Science, stated, "The registration of this patent in Canada has further strengthened the foundation for objectively evaluating the osteoarthritis treatment efficacy of TG-C," adding, "This is an important achievement in enhancing scientific credibility for global market entry."

This content was produced with the assistance of AI translation services.